- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509766
Randomized Evaluation of Ten Allergy Skin Prick Test Devices
August 14, 2018 updated by: Johns Hopkins University
The goal of this study is to compare ten current and readily available FDA approved allergy skin prick devices to determine the most sensitive and specific product and methods used for the diagnosis of allergic disease.
The primary outcome will be to determine the analytical sensitivity and specificity of all ten skin prick devices by measuring wheal and flare response to histamine and control diluent in 1mm increments.
Secondary outcomes include comparison of skin prick technique, optimum histamine concentration, patient comfort, reproducibility, and the comparability of high-resolution digital images.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- John Hopkins Asthma and Allergy Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults aged 18-65 with or without allergic disease
Exclusion Criteria:
- severe concurrent illness
- uncontrolled asthma
- extensive eczema
- urticaria
- dermatographism
- pregnancy
- those taking antihistamines within the previous 10 days
- topical steroids
- immunomodulatory drugs
- long term use of oral steroids
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Skin testing
All subject both allergic and non-allergic will be tested.
There is only one (1) arm.
|
skin testing using histamine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wheal Response
Time Frame: 15 minutes
|
Compare Wheal response among devices using 1mm precision.
SPT test will be read at 15 min time point.
The maximum wheal diameter will be recorded for each of ten skin prick devices.
3mm (and 2mm above negative control) qualify as a positive test.
|
15 minutes
|
Sensitivity
Time Frame: 15 minutes
|
Sensitivity is calculated by dividing the true positive wheals divided by true positives plus false negatives and multiplying by 100.
For example one false negative out of 24 tests equals a sensitivity of 95.8%.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Prick Techniques/Methodology Ratio
Time Frame: 15 minutes
|
Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method.
Maximum wheal diameter is measured for each concentration.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
December 27, 2013
First Submitted That Met QC Criteria
April 17, 2018
First Posted (ACTUAL)
April 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 16, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Nose Diseases
- Hypersensitivity
- Rhinitis
- Rhinitis, Allergic
- Food Hypersensitivity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Histamine Agents
- Histamine Agonists
- Histamine
Other Study ID Numbers
- NA_00092406
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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